Chris Ryan

The FDA has approved nogapendekin alfa inbakicept-pmln plus BCG for BCG-unresponsive non–muscle-invasive bladder cancer with carcinoma in situ with or without papillary tumors.

Health Canada has approved pembrolizumab plus chemotherapy for first-line, locally advanced, unresectable, or metastatic, HER2-negative gastric/GEJ cancer.

The FDA has approved alectinib as adjuvant treatment in select patients with ALK-positive non–small cell lung cancer.

The FDA has approved the optical imaging agent Lumisight and the Lumicell Direct Visualization System for use in fluorescence imaging in breast cancer.

Serial testing of ctDNA could improve risk stratification for determining adjuvant treatment in patients with high-risk muscle-invasive bladder cancer.

The PET imaging agent TLX101-CDx has received FDA fast track designation for the characterization of progressive or recurrent glioma.

The FDA has received a type C meeting request from Oncolytics Biotech to discuss a registration-enabling trial for pelareorep in HR+/HER2– breast cancer.

Experts from across the oncology field highlight their biggest takeaways and the hottest topics from the 2024 AACR Annual Meeting.

The FDA granted accelerated approval to trastuzumab deruxtecan for pretreated, unresectable or metastatic HER2-positive solid tumors.

The cancer vaccine immunotherapeutic VBI-1901 generated disease control in patients with recurrent glioblastoma.

A rolling BLA for zanidatamab in previously treated, HER2-positive, advanced biliary tract cancer has been submitted to the FDA.

The FDA has accepted a biologics license application for datopotamab deruxtecan in HR-positive, HER2-negative metastatic breast cancer.

China’s NMPA accepted a sBLA for enfortumab vedotin plus pembrolizumab for the first-line treatment of locally advanced or metastatic urothelial cancer.

The European Commission has approved neoadjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab, for high-risk, resectable NSCLC.

Capivasertib plus fulvestrant has been approved in Japan for pretreated, PIK3CA-, AKT1-, or PTEN-altered, HR-positive, HER2-negative breast cancer.

The FDA granted priority review to the NDA seeking the approval of revumenib for the treatment of relapsed/refractory, KMT2A-rearranged acute leukemia.

Liposomal annamycin plus cytarabine elicited responses in patients with acute myeloid leukemia, according to interim data from the phase 1b/2 MB-106 trial.

The FDA issued complete response letters to the BLA for odronextamab in relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma.

Patients with non–small cell lung cancer treated on the IMscin002 trial preferred subcutaneous atezolizumab vs the intravenous formulation.

The FDA has approved safety label changes for fluorouracil products to include information regarding the agent’s use in patients with DPD.

Pembrolizumab plus olaparib as first-line maintenance therapy did not improve survival in patients with metastatic nonsquamous non–small cell lung cancer.

Perioperative nivolumab improved responses in resectable non–small cell lung cancer, irrespective of the number of neoadjuvant treatment cycles completed.

A phase 1b trial is investigating the novel GCN2 kinase activator NXP800 in patients with platinum-resistant, ARID1A-mutated ovarian cancer.

Liquid nitrogen–based cryoablation elicited a 5-year local RFS rate of 96.39% in patients with low-risk, early-stage breast cancer.

China’s NMPA has approved tunlametinib for the treatment of patients with NRAS-mutated advanced melanoma after prior anti–PD-1/PD-L1 therapy.

Social determinants of health were associated with geographical variations in the rates of cervical cancer in the United States.

The FDA’s Oncologic Drugs Advisory Committee voted in favor of idecabtagene vicleucel for patients with early relapsed/refractory myeloma.

The FDA’s Oncologic Drugs Advisory Committee voted in favor of ciltacabtagene autoleucel for patients with early relapsed/refractory myeloma.

Nina Sanford, MD, discusses how radiation could help improve QOL for patients with rectal cancer and situations when radiation or surgery could be omitted.

A new drug application seeking the approval of Dato-DXd for pretreated HR-positive, HER2-negative advanced breast cancer has been filed in Japan.